FDA approves 18 Ranbaxy drugs despite FDA investigation

WASHINGTON Ranbaxy, which was recently purchased by Daiichi Sankyo, and is dealing with an investigation from the Food and Drug Administration over whether it fabricated data to get medicines approved, has had 18 generic drugs approved by the agency since the beginning of the investigation of the company over a year ago, according to Bloomberg.

Lawmakers and former FDA officials are now questioning why the agency continued to trust Ranbaxy’s data on new products after learning of the allegations. The House Energy and Commerce Committee, which oversees the FDA, is probing why the agency didn’t act on the information, described by the Justice Department in a court motion last month seeking documents from the company.

On July 3, the government asked a U.S. District Court judge in Maryland to force the company to turn over audits completed by a contractor, which Ranbaxy later agreed to provide. According to the motion, the government is investigating allegations including conspiracy; false statements and health- care fraud.

Because the investigation is continuing, the FDA won’t comment on why it hasn’t blocked approval of Ranbaxy products, said spokeswoman Julie Zawisza.